Peripheral artery disease (PAD) affects millions of people in the United States alone. PAD is a silent, dangerous disease that can have catastrophic consequences when left untreated. PAD is the leading cause of amputation in patients over 50 and is responsible for approximately 160,000 amputations in the United States each year.
Peripheral artery disease (PAD) is a progressive narrowing of the blood vessels most often caused by atherosclerosis, the collection of plaque or a fatty substance along the inner lining of the artery wall. Over time, this substance hardens and thickens, which may interfere with blood circulation to the arms, legs, stomach and kidneys. This narrowing forms an occlusion, completely or partially restricting flow through the artery. The most significant of these occlusions are called chronic total occlusions (CTO). Blood circulation to the brain and heart may be reduced by CTOs, increasing the risk for stroke and heart disease.
Interventional treatments for PAD may include endarterectomy and/or atherectomy. Endarterectomy is surgical removal of plaque from the blocked artery to restore or improve blood flow. Endovascular therapies such as atherectomy are typically minimally invasive techniques that open or widen arteries that have become narrowed or blocked. Other treatments may include angioplasty to open the artery. For example, a balloon angioplasty typically involves insertion of a catheter into a leg or arm artery and is positioned such that the balloon resides within the blockage. The balloon, connected to the catheter, is expanded to open the artery. Surgeons may then place a wire mesh tube, called a stent, at the area of blockage to keep the artery open.
Traditional atherectomy devices have been plagued by a number of problems that have severely limited market adoption of these devices. These challenges include the following: (1) the need for large vessel access devices; (2) the presence of rigid distal assembles, which make device introduction and control challenging; (3) the need for a fixed and predictable cut length; (4) the need for predictable cut depth; (5) the desire for sufficient tissue collection and removal; and (6) the need for simplified user operation. The systems and devices described herein may overcome these hurdles and give physicians a safe, reliable, and simple cutting system that enables the precision required in eccentric lesions, various disease states, and tortuous anatomy.
Further, many minimally invasive techniques (e.g., atherectomy, angioplasty, etc.) require either rotational and/or longitudinal motion of components (e.g. for cutting, imaging, and/or packing of tissue). Such activation, however, generally requires use of a drive system connected to the catheter. Disposable drive systems, however, are expensive and impractical. On the other hand, reusable drive systems can be problematic for keeping the surgical field sterile. What is needed, therefore, is a reusable drive system that can easily be kept in the sterile field.